04 November 2008

New IRB members (part 2)

Please welcome additional new members to the UMBC Institutional Review Board who began in the Fall of 2008:

Sarah Chard, Assistant Professor, Anthropology/Sociology

Joseph Clift, Managing Associate/Project Manager, Association for the Study and Development of Community

The updated roster of Board membership is available on the IRB website.

Do surveys created for improving services and programs at UMBC need IRB review?

A question that comes up not only at UMBC, but at other institutions as well. And, is IRB review required? It depends.

Surveys that are for quality improvement/quality assurance or for developing new services or programs for students, employees, or alumni, may not need IRB review. Surveyors should keep in mind that privacy of the participants needs to be protected, the confidentiality of individual responses is maintained, and survey participation is voluntary.

If, at a future date, an opportunity will arise to contribute previously collected survey data to a new project producing generalizable knowledge, an application for IRB review would be required before the data could be released to the new project.

The IRB has developed a QI/QA algorithm to help sort this out.

Who signs a consent form?

Federal regulations (45 CFR 46.117) require written informed consent, one that is approved by the IRB and signed by the participant or the participant's legal representative and the principal investigator (or his/her delegate). The delegated responsibility can fall to members of the investigator's “research team”, provided the team members have been trained by the investigator and had also taken the UMBC Collaborative Institutional Training Initiative (CITI) web-based course.

Consent forms should be signed by the person actually administering consent, at the time consent is administered, attesting to the informed consent conversation. At no time should the consent forms be pre-signed by the members of the research team.

Further details about the consent process may be found at http://www.umbc.edu/research/HARPO/IRB/consentassent.html

10 September 2008

How long does the IRB take to review and approve a protocol?

CHECK IT OUT! http://www.umbc.edu/irb/howtosubmitaprotocol.htm

Adding or changing training modules on CITI

So, you've taken the CITI training - thank you! But, your mentor/supervisor has suggested that you take additional training to supplement the work you'll perform the lab or continue with, say, your dissertation research. To change the CITI course registration that will fit your training requirements, you will have to switch "learner groups". All it takes is going through a couple of steps.

1) Log back into CITI (using your username and password). The site that appears will be your "Learner's Menu" page - the one that shows the courses you're enrolled in.

2) Scroll down and look for the link that says "Add a course or update your learner groups for University of Maryland, Baltimore County". Click on that and find the "Update Groups" link.

3) This is your "Groups" page. Scroll down the page that lists the CITI Course Enrollment Questions. Select the radio button next to "Data or Specimens Only Research" OR "Researchers Conducting Less than Minimal Risk" OR "Social & Behavioral Minimal Risk Research", then continue scrolling to the bottom of the page and hit the submit button.

4) You'll now be back at your "Groups" page. Go to the bottom of the next page and click on the "Go Back to Learner's Main Menu" link.

5) You'll then be back at your "Learner's Menu" page. You’ll see a link that says "Human Research" under My Courses. The original Human Research link should now say "Not Started - Enter". Click on that link and you'll see a list of additional training modules to take. Continue with reviewing the training materials and taking the quizzes. Once completed, you'll have a new certificate showing the completed modules.

Of course, if you have any questions about these steps, contact HARPO at 5-2737 or HARPO@umbc.edu.

05 September 2008

How to access the CITI training

As the new semester begins, we at HARPO get quite a few questions on how to access the CITI (or Collaborative Institutional Training Initiative) web based training programs.

First, what is CITI? The CITI program is a web-based subscription training service that provides research ethics education to all members of the research community. UMBC subscribes to this service, but you must register to create your own username and password and gain access to the site.

Now, who needs to take what training? Investigators working with people (that means conducting surveys, interviews, assessments, or looking at a person's data) will take training modules related to the IRB or human research. The modules cover topics dealing with social and behavioral research, high or low risk studies and projects looking at previously collected data or specimens. Investigators working with animals will take training related to animal care and use. There are also modules involving topics of responsible conduct of research, such as research misconduct, conflict of interest, publication practices & responsible authorship.

Finally, how can you access it? Pretty easy - go to HARPO training page (http://www.umbc.edu/HARPO/training.html) and select the training that's appropriate for your research. The important thing to remember is to log into the CITI site when you're ready to begin. Remember this: https://www.citiprogram.org/.

22 August 2008

CORRECTION! New IRB members

As reported earlier, Satarupa Joardar, was listed as a Graduate student member in Biological Sciences. Correctly, she is a graduate student in the Intercultural Communication program in the Modern Languages and Linguistics department. Mea culpa, Mea culpa.